Stent-graft delivery system having a rotatable single shaft tip capture mechanism

ABSTRACT

A stent-graft delivery system includes an elongate shaft, a tip capture spindle disposed over the shaft, and a distal tip assembly coupled to the distal end of the shaft. At least one component of the delivery system constrains a stent of the stent-graft engaged with the tip capture spindle during delivery and partial-deployment of the stent-graft, and the at least one component is in a threaded relationship with the distal tip assembly. To fully deploy the stent-graft, the elongate shaft, having the distal tip assembly coupled thereto, is rotated to result in longitudinal movement of the at least one component and thereby release the stent from the tip capture spindle. The at least one component that longitudinally moves to fully deploy the stent-graft may be the tip capture spindle and/or a relatively short sleeve that extends over the tip capture spindle to the distal tip assembly.

FIELD OF THE INVENTION

The invention is related in general to implantable prostheses and inparticular to self-expanding stent-grafts.

BACKGROUND OF THE INVENTION

Prostheses for implantation in blood vessels or other similar organs ofthe living body are, in general, well known in the medical art. Forexample, prosthetic vascular grafts constructed of biocompatiblematerials have been employed to replace or bypass damaged or occludednatural blood vessels. In general, endovascular grafts typically includea graft anchoring component that operates to hold a tubular graftcomponent of a suitable graft material in its intended position withinthe blood vessel. Most commonly, the graft anchoring component is one ormore radially compressible stents that are radially expanded in situ toanchor the tubular graft component to the wall of a blood vessel oranatomical conduit. Thus, endovascular grafts are typically held inplace by mechanical engagement and friction due to the opposition forcesprovided by the radially expandable stents.

Grafting procedures are also known for treating aneurysms. Aneurysmsresult from weak, thinned blood vessel walls that “balloon” or expanddue to aging, disease and/or blood pressure in the vessel. Consequently,aneurysmal vessels have a potential to rupture, causing internalbleeding and potentially life threatening conditions. Grafts are oftenused to isolate aneurysms or other blood vessel abnormalities fromnormal blood pressure, reducing pressure on the weakened vessel wall andreducing the chance of vessel rupture. As such, a tubular endovasculargraft may be placed within the aneurysmal blood vessel to create a newflow path and an artificial flow conduit through the aneurysm, therebyreducing if not nearly eliminating the exertion of blood pressure on theaneurysm.

In general, rather than performing an open surgical procedure to implanta bypass graft that may be traumatic and invasive, endovascular graftswhich may be referred to as stent-grafts are preferably deployed througha less invasive intraluminal delivery procedure. More particularly, alumen or vasculature is accessed percutaneously at a convenient and lesstraumatic entry point, and the stent-graft is routed through thevasculature to the site where the prosthesis is to be deployed.Intraluminal deployment is typically effected using a delivery catheterwith coaxial inner and outer tubes arranged for relative axial movement.For example, a self-expanding stent-graft may be compressed and disposedwithin the distal end of an outer catheter tube distal of a stop fixedto the inner member. The catheter is then maneuvered, typically routedthrough a body lumen until the end of the catheter and the stent-graftare positioned at the intended treatment site. The stop on the innermember is then held stationary while the outer tube of the deliverycatheter is withdrawn. The stop prevents the stent-graft from beingwithdrawn with the sheath. As the sheath is withdrawn, the stent-graftis released from the confines of the sheath and radially self-expands sothat at least a portion of it contacts and substantially conforms to aportion of the surrounding interior of the lumen, e.g., the blood vesselwall or anatomical conduit.

In recent years, to improve optimal control and alignment duringdeployment and positioning of a stent-graft, various tip capturespindles have been incorporated into the delivery system utilized forpercutaneously delivering the stent-graft prosthesis. Tip captureinvolves restraining the proximal end stent of the stent-graft in aradially compressed configuration in conjunction with the main bodyrestraint achieved by other delivery system components, such as atubular cover shaft or sheath. The tip capture spindle can be activatedat any time during stent-graft deployment to suit any number of systemcharacteristics driven by the therapy type, stent-graft type, orspecific anatomical conditions that may prescribe the release timing.Typically, the tip capture release is activated after some or all themain stent-graft body release, and thus provides a mean of restrainingthe stent-graft during positioning and any re-positioning. Additionalrestraint of the stent-graft is a key characteristic when the operatoris attempting to accurately position the stent relative to an anatomicaltarget. The tip capture restraint also aids in reducing an abrupt forceof expansion when the stent-graft is released from the graft cover orsheath.

For example, U.S. Patent Application Publication No. 2006/0276872 toArbefuielle et al. and U.S. Patent Application Publication No.2009/0276027 to Glynn et al., both herein incorporated by reference intheir entirety, describe tip capture mechanisms that restrain theproximal end stent of the stent-graft while the remainder of thestent-graft expands, then releases the proximal end stent. The proximalend stent (sometimes also referred to as the anchor stent) is attachedto the graft material of the stent-graft so as to have an “open web” or“free flow” proximal end configuration in which the proximal endmostcrowns thereof extend past or beyond the graft material such that theproximal endmost crowns are exposed or bare, and thus free to interactwith a tip capture mechanism and couple the stent-graft prosthesis tothe delivery system. FIGS. 1A and 1B illustrate a delivery system 10having a tip capture spindle 12 designed to couple or interact with astent-graft 14 having an open web or free flow proximal endconfiguration 16. More particularly, endmost crowns 18 engage or hookaround retractable arms or retainer elements 20 of the tip capturespindle 12. Delivery system 10 includes at least three concentricshafts, namely an outer delivery sheath or graft cover 22, anintermediate shaft 24 coupled to tip capture spindle 12, and an elongateinner shaft 26 coupled to distal tip assembly 28. When graft cover 22 isretracted to allow stent-graft 14 to self-expand, endmost crowns 18 ofthe end stent 15 remain hooked around tip capture retainer elements 20,as shown in FIG. 1A. To release end stent 15, intermediate shaft 24coupled to tip capture spindle 12 is retracted longitudinally relativeto inner shaft 26 to retract tip capture spindle 12 such that end stent15 is released from tip capture spindle 12 and allowed to self-expand,as shown in FIG. 1B. The Captivia Delivery System manufactured byMedtronic Vascular, Inc. of Santa Rosa, Calif. is one example of adelivery system having a tip capture mechanism as described above, whichmay be utilized for delivering endovascular stent-grafts such as theValiant Thoracic Stent-graft manufactured by Medtronic Vascular, Inc. ofSanta Rosa, Calif..

Tip capture mechanisms have improved accuracy of deployment ofself-expanding stent-grafts. However, tip capture mechanisms known inthe art require two or more concentric shafts, in addition to the outersheath, such as intermediate shaft 24 and elongate inner shaft 26described above with respect to FIG. 1 to retract the tip capturespindle and fully deploy the stent-graft. Two or more concentric shaftswithin the delivery system may cause several trackability and deploymentchallenges. More particularly, two or more concentric shafts increasethe delivery or crossing profile of the delivery system. In addition,release forces associated with a delivery system having two or moreconcentric shafts that slide longitudinally relative to each other arerelatively higher than a delivery system not requiring two or moreconcentric shafts because frictional forces between the two concentricshafts must be overcome to release the stent-graft from the tip capturespindle. Further, premature release of the stent-graft may occur when auser is attempting to maneuver the delivery system during repositioningof the stent-graft. When positioning or repositioning the deliverysystem, the user must push or pull the delivery system longitudinally.Due to the force required to push or pull the delivery system throughtortuous vessels, the concentric shafts 24, 26 of the tip capture systemmay slide relative to each other, thereby causing premature release ofthe stent-graft from the tip capture spindle. Embodiments hereof relateto a delivery system having a tip capture mechanism to allow for partialdeployment and repositioning of the stent-graft, wherein the deliverysystem more efficiently retracts the tip capture spindle.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof relate to a stent-graft delivery system including anelongate shaft, a tip capture spindle disposed over the shaft, a distaltip assembly coupled to the distal end of the shaft, and a stent-graftprosthesis mounted over the shaft. The stent graft prosthesis includes astent coupled to a tubular graft. The tip capture spindle includes aplurality of retainer elements engaged with the stent of a stent-graftprosthesis. At least one component of the stent-graft delivery systemconstrains the stent engaged with the tip capture spindle into adelivery configuration and/or a partially-deployed configuration, androtation of the elongate shaft results in longitudinal movement of theat least one component to release the stent from the tip capture spindleinto a fully deployed configuration.

Embodiments hereof also relate to a stent-graft delivery systemincluding an elongate shaft, a tip capture spindle disposed over theshaft, proximate to a distal end of the shaft, and a distal tip assemblycoupled to the distal end of the shaft. A proximal portion of the tipcapture spindle includes a plurality of retainer elements configured toengage a stent of a stent-graft prosthesis and a distal portion of thetip capture spindle includes threads on an outer surface thereof. Aportion of the distal tip assembly proximally extends over the outersurface of the distal portion of the tip capture spindle and an innersurface of the proximally-extending portion of the distal tip assemblyincludes threads that mate with the threads on the tip capture spindle.Rotation of the elongate shaft rotates the distal tip assembly andresults in longitudinal movement of the tip capture spindle.

Embodiments hereof also relate to a method of deploying a stent-graftprosthesis. A stent-graft delivery system is percutaneously advanced.The delivery system has a stent-graft prosthesis mounted on an elongateshaft, wherein a tip capture spindle is disposed over the shaft and aproximal portion of the tip capture spindle includes a plurality ofretainer elements engaged with a stent of the stent-graft prosthesis. Adistal tip assembly is coupled to a distal end of the shaft and aportion of the distal tip assembly proximally extends over an outersurface of a distal portion of the tip capture spindle. An inner surfaceof the distal tip assembly includes threads that mate with threadsformed on the outer surface of the distal portion of the tip capturespindle. The stent-graft prosthesis is positioned and is partiallydeployed by retracting an outer sheath of the delivery system to exposethe stent-graft prosthesis, wherein the stent-graft prosthesisself-expands and the stent remains engaged with the plurality ofretainer elements of the tip capture spindle. The elongate shaft isrotated to fully deploy the stent-graft prosthesis, wherein rotation ofthe elongate shaft rotates the distal tip assembly and results inlongitudinal movement of the tip capture spindle.

Embodiments hereof also relate to a stent-graft delivery systemincluding an elongate shaft, a tip capture spindle disposed over theshaft, proximate to a distal end of the shaft, and a distal tip assemblycoupled to the distal end of the shaft. The tip capture spindle includesa plurality of retainer elements configured to engage a stent of astent-graft prosthesis. A portion of the distal tip assembly proximallyextends over elongate shaft and an outer surface of the distal tipassembly includes threads. A sleeve extends over the retainer elementsof the tip capture spindle to the distal tip assembly. An inner surfaceof the sleeve includes threads that mates with the threads on outersurface of the distal tip assembly, and rotation of the elongate shaftrotates the distal tip assembly and results in longitudinal movement ofthe sleeve.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following description of embodiments hereof asillustrated in the accompanying drawings. The accompanying drawings,which are incorporated herein and form a part of the specification,further serve to explain the principles of the invention and to enable aperson skilled in the pertinent art to make and use the invention. Thedrawings are not to scale.

FIGS. 1A and 1B are side views of a distal end of a delivery systemhaving a tip capture spindle designed to couple or interact with astent-graft having an open web or free flow proximal end configuration.

FIG. 2 is a side view of a stent-graft delivery system having a singleelongate shaft for a tip capture mechanism according to an embodimenthereof, wherein a stent-graft prosthesis mounted on the delivery systemis in a delivery configuration.

FIG. 2A is a cross-sectional view taken along the line A-A of FIG. 2.

FIG. 2B is a cross-sectional view taken along the line B-B of FIG. 2.

FIG. 3 is a side view of a distal portion of the stent-graft deliverysystem of FIG. 2, wherein the stent-graft is in a partially deployedconfiguration.

FIG. 4 is a perspective view of a distal portion of the stent-graftdelivery system of FIG. 2, wherein the stent-graft is in a partiallydeployed configuration.

FIG. 4A is a cross-sectional view of FIG. 4.

FIG. 5 is a side view of a distal portion of the stent-graft deliverysystem of FIG. 2, wherein the stent-graft is in a fully deployedconfiguration.

FIG. 6 is a perspective view of a distal portion of the stent-graftdelivery system of FIG. 2, wherein the stent-graft is in a fullydeployed configuration.

FIG. 6A is a cross-sectional view of FIG. 6.

FIG. 7 is a perspective view of a distal portion of a stent-graftdelivery system having a single elongate shaft for a tip capturemechanism according to another embodiment hereof, wherein a stent-graftprosthesis mounted on the delivery system has a closed-web proximal endconfiguration and is in a delivery or partially-deployed configuration.

FIG. 7A is a cross-sectional view of FIG. 7.

FIG. 8 is a proximal end view taken along line A-A of FIG. 7.

FIG. 9 is an enlarged sectional perspective view of a portion of FIG. 7.

FIG. 10 is a perspective view of a distal portion of the stent-graftdelivery system of FIG. 7, wherein the stent-graft prosthesis is in afully deployed configuration.

FIG. 10A is a cross-sectional view of FIG. 10.

FIG. 11 is a perspective view of a distal portion of a stent-graftdelivery system having a single elongate shaft for a tip capturemechanism according to another embodiment hereof, wherein a barbedstent-graft prosthesis mounted on the delivery system is in a deliveryor partially-deployed configuration.

FIG. 11A is a cross-sectional view of FIG. 11.

FIG. 11B is an enlarged view of a portion of FIG. 11A.

FIG. 12 is a cross-sectional view of the distal portion of thestent-graft delivery system of FIG. 11B, wherein the stent-graftprosthesis is in a fully deployed configuration.

FIG. 13 is a perspective view of a distal portion of a stent-graftdelivery system having a single elongate shaft for a tip capturemechanism according to another embodiment hereof, wherein a barbedstent-graft prosthesis mounted on the delivery system is in a deliveryor partially-deployed configuration and the delivery system includes twocomponents that are moved in opposing longitudinal directions duringdeployment of the stent-graft prosthesis.

FIG. 13A is a cross-sectional view of FIG. 13.

FIG. 13B is an enlarged view of a portion of FIG. 13A.

FIG. 14A is a cross-sectional view of the distal portion of thestent-graft delivery system of FIG. 13, wherein the stent-graftprosthesis is in a fully deployed configuration.

FIG. 14B is an enlarged view of a portion of FIG. 14A.

FIG. 15 is a cross-sectional view of a distal portion of a stent-graftdelivery system having a single elongate shaft for a tip capturemechanism according to another embodiment hereof, wherein a barbedstent-graft prosthesis mounted on the delivery system is in a deliveryor partially-deployed configuration and the delivery system includes twocomponents in a double threaded relationship that are moved in opposinglongitudinal directions during deployment of the stent-graft prosthesis.

FIG. 16 is a cross-sectional view of the distal portion of thestent-graft delivery system of FIG. 15, wherein the stent-graftprosthesis is in a fully deployed configuration.

FIG. 16A is an enlarged perspective view of a portion of FIG. 16,wherein the stent-graft prosthesis and the elongate shaft of thedelivery shaft have been omitted for clarity.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. Specific embodiments are nowdescribed with reference to the figures, wherein like reference numbersindicate identical or functionally similar elements. Unless otherwiseindicated, for the delivery system the terms “distal” and “proximal” areused in the following description with respect to a position ordirection relative to the treating clinician. “Distal” and “distally”are positions distant from or in a direction away from the clinician,and “proximal” and “proximally” are positions near or in a directiontoward the clinician. For the stent-graft prosthesis “proximal” is theportion nearer the heart by way of blood flow path while “distal” is theportion of the stent-graft further from the heart by way of blood flowpath. In addition, the term “self-expanding” is used in the followingdescription with reference to one or more stent structures of theprostheses hereof and is intended to convey that the structures areshaped or formed from a material that can be provided with a mechanicalmemory to return the structure from a compressed or constricted deliveryconfiguration to an expanded deployed configuration. Non-exhaustiveexemplary self-expanding materials include stainless steel, apseudo-elastic metal such as a nickel titanium alloy or nitinol, variouspolymers, or a so-called super alloy, which may have a base metal ofnickel, cobalt, chromium, or other metal. Mechanical memory may beimparted to a wire or stent structure by thermal treatment to achieve aspring temper in stainless steel, for example, or to set a shape memoryin a susceptible metal alloy, such as nitinol. Various polymers that canbe made to have shape memory characteristics may also be suitable foruse in embodiments hereof to include polymers such as polynorborene,trans-polyisoprene, styrene-butadiene, and polyurethane. As well polyL-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octinecan be used separately or in conjunction with other shape memorypolymers.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Although the description of the invention is in the contextof treatment of blood vessels such as the aorta, coronary, carotid andrenal arteries, the invention may also be used in any other bodypassageways where it is deemed useful. Furthermore, there is nointention to be bound by any expressed or implied theory presented inthe preceding technical field, background, brief summary or thefollowing detailed description.

Embodiments hereof relate to stent-graft delivery systems having a tipcapture mechanism that allows for partial deployment and repositioningof the stent-graft prosthesis. Rather than retraction of an intermediateor outer shaft over an inner shaft for final deployment of thestent-graft prosthesis as required in prior delivery systems describedabove, a single elongate shaft is rotated for final deployment or tiprelease of the stent-graft prosthesis. In embodiments hereof, as will beexplained in more detail below, a tip capture spindle which holds orretains an end stent of the stent-graft prosthesis is in a threadedrelationship with a distal tip assembly of the delivery system. Thedistal tip assembly is coupled or attached to the single elongate shaftsuch that rotation of the shaft also rotates the distal tip assembly.When the elongate shaft and distal tip assembly are rotated, therotational movement is converted to translational or linear movement ofthe tip capture spindle due to the threaded relationship between thespindle and the distal tip assembly. As a result, the tip capturespindle may be longitudinally driven back or forth to release the endstent for final deployment of the stent-graft prosthesis. Release forcesare thus improved due to the mechanical advantage of threads used toconvert rotational movement of the shaft into translational movement ofthe tip capture spindle. The rotational forces to rotate the singleshaft and thereby actuate tip release are significantly less than forcesrequired to move or retract an intermediate shaft over an inner shaft inthe prior systems described above. More particularly, when being trackedthrough a vasculature, the shaft(s) of a delivery system take on theshape of the vascular system and frictional issues may arise. If thedelivery system includes concentric intermediate and inner shafts as inthe prior systems described above, the shafts move within one anotheralong their shared axis and the frictional elements that occur at everynode or turn of tortuosity are additive and rapidly become significant.The required tensile limits of the concentric shafts result in anincreased wall thickness of the shafts, thus reducing useful crosssectional area of the delivery system profile. On the other hand, if ashaft of the delivery system turns or rotates around its longitudinalaxis, the torque transmitted through the shaft to actuate the tipcapture is modest or minimal. The polar moment of inertia necessary toturn/rotate the shaft is also low and is not affected by tortuosity.Accordingly, in embodiments hereof in which only a single elongate shaftis rotated, the elongate intermediate or outer shaft eliminated and therequired tensile limits of the single elongate shaft do not result in anincreased wall thickness, thereby minimizing the wall thickness andmaterial requirements of the rotatable shaft.

According to an embodiment hereof, a delivery system 200 having a tipcapture mechanism to allow for partial deployment and repositioning ofthe stent-graft is shown and described with respect to FIGS. 2-6. FIGS.2, 2A, and 2B illustrate delivery system 200 for delivering aself-expanding stent-graft prosthesis 230 within a vasculature, whereinstent-graft prosthesis 230 is in a compressed delivery configuration.FIG. 2 is a schematic side view of system 200, while FIG. 2A is across-sectional view taken along line A-A of FIG. 2 and FIG. 2B is asectional view taken along line B-B of FIG. 2. FIGS. 3 and 4 illustratea distal portion of delivery system 200 in a partially deployedconfiguration, and FIGS. 5 and 6 illustrate a distal portion of deliverysystem 200 in a deployed configuration. In FIG. 6, stent-graftprosthesis 230 is still shown with first end stent 240A undeployed forconvenience of seeing the relationship between the stent-graft 230 andthe delivery system 200, but it would be understood by those havingordinary skill in the art that once tip capture spindle 224 is retractedsuch that crowns 242A of first end stent 240A are not retained byspindle 224, first end stent 240A will self-expand to fully deploy stentgraft prosthesis 230, as described in more detail below.

Stent-graft delivery system 200 includes an elongate shaft 212 having aproximal end 214 and a distal end 216 (shown in cross-sectional views ofFIGS. 4A and 6A), and a distal tip assembly 228 is coupled to distal end216 of elongate shaft 212. Elongate shaft 212 may be constructed from aflexible metal tube of NiTi (Nitinol™), stainless steel, or the like, ormay be constructed of a rigid plastic tube of PEEK polyetheretherketone,polyimide, or the like. Elongate shaft 212 may have any suitable workinglength, for example, 550 mm-600 mm, to extend to a target location wherestent-graft 230 is to be implanted. Distal tip assembly 228 may betapered and flexible to provide trackability through the vasculature.Those skilled in the art will appreciate that distal tip assembly 228can be formed as a single unit and/or assembled from individual parts orcomponents. Distal tip assembly 228 can be constructed by insert moldingone or more components thereof over elongate shaft 212. Suitablematerials for distal tip assembly 228 include Pebax, urethane, silicone,other flexible polymers, and the like, any of which may also include aradiopaque additive to provide the clinician with a visible tip whenusing fluoroscopy guidance to deliver the stent-graft within thepatient. In an embodiment, elongate shaft 212 may define a guidewirelumen 218 for receiving a guidewire 222 there through. Elongate shaft212 may be advanced over an indwelling guidewire to track the deliverysystem to the target site. Alternatively, elongate shaft 212 may insteadbe a solid rod (not shown) without a lumen extending there through. Inan embodiment where elongate shaft 212 is a solid rod, elongate shaft212 is tracked to the target site with the assistance of tapered distaltip assembly 228. In addition, delivery system 200 may include aradiopaque marker (not shown) allowing for accurate positioning of thedelivery system prior to deployment of the stent-graft.

Stent-graft prosthesis 230 is disposed around elongate shaft 212,proximate to distal end 216 thereof. Stent-graft prosthesis 230 includesa tubular graft 232 having a first edge or end 234, a second edge or end236, and a body 238 there between which defines a lumen (not shown)through stent-graft prosthesis 230. In an embodiment, first end 234 ofgraft 232 may be referred to as a proximal end of graft 232 and aproximal end of stent-graft prosthesis 230, which is conventionally theend that is coupled to a tip capture mechanism of a delivery system, andsecond end 236 of graft 232 may be referred to as a distal end of graft236 and a distal end of stent-graft prosthesis 230. Graft 232 may beformed from any suitable graft material, for example and not limited to,a low-porosity woven or knit polyester, DACRON material, expandedpolytetrafluoroethylene, polyurethane, silicone, or other suitablematerials. In another embodiment, the graft material could also be anatural material such as pericardium or another membranous tissue suchas intestinal submucosa. Stent-graft prosthesis 230 also includes atleast one radially-compressible stent or scaffold 240 that is coupled tograft 232 for supporting the graft material and that is operable toself-expand into apposition with an interior wall of a body vessel (notshown). In the embodiment depicted in FIG. 2B, stent-graft prosthesis230 includes a series of five independent or separate cylindrical stents240. Each stent 240 is constructed from a self-expanding or springmaterial, such as Nitinol, and is a sinusoidal patterned ring includinga plurality of crowns or bends 242 and a plurality of struts or straightsegments 244 with each crown being formed between a pair of opposingstruts. Although shown with five stents 240, it will be understood bythose of ordinary skill in the art that stent-graft prosthesis 230 mayinclude a greater or smaller number of stents 240 depending upon thedesired length of stent-graft prosthesis 230 and/or the intendedapplication thereof. For description purposes only, the stent that iscoupled adjacent and proximate to first end 234 of graft 232 is referredto herein as first end stent 240A and the stent that is coupled adjacentand proximate to second end 236 of graft 232 is referred to herein assecond end stent 240B but it will be understood by those of ordinaryskill in the art that all of the stents may have identical or differentpatterns or configurations. Stents 240 are coupled to graft 232 bystitches or other means known to those of skill in the art. In theembodiment shown in FIG. 2, stents 240 are coupled to an outer surfaceof graft 232. However, stents 240 may alternatively be coupled to aninside surface of graft 232. When stent-graft prosthesis 230 is used fortreating an aneurysm, stents 240 have sufficient radial spring force andflexibility to conformingly engage stent-graft prosthesis 230 with thebody lumen inner wall, to avoid excessive leakage, and preventpressurization of the aneurysm, i.e., to provide a leak-resistant seal.Although some leakage of blood or other body fluid may occur into theaneurysm isolated by stent-graft prosthesis 230, an optimal seal willreduce the chances of aneurysm pressurization and resulting rupture.

In the embodiment of FIGS. 2-6, stent-graft 230 has an open-web orfree-flow proximal end configuration. The open web proximal endconfiguration allows blood flow through endmost crowns 242A forperfusion during and/or after implantation. As utilized herein, “endmostcrowns” refers to the most proximal crowns or peaks of the stent-graftprosthesis, regardless of whether or not the crowns are coupled to thegraft material or whether the crowns extend beyond the edge of the graftmaterial. More particularly, first end stent 240A is attached to graft232 so that endmost crowns 242A thereof extend past or beyond the graftmaterial such that the endmost crowns are exposed or bare, and thus freeto interact with a tip capture spindle 224 and couple stent-graftprosthesis 230 to delivery system 200. Tip capture spindle 224 functionsto retain or hold first end 234 of stent-graft prosthesis 230 duringdelivery. Tip capture spindle 224 is disposed around elongate shaft 212and is rotatable relative to shaft 212. In the delivery configurationshown in FIG. 2B endmost crowns 242A of first end stent 240A engage orhook around retainer elements 226 of tip capture spindle 224. Retainerelements 226 are formed on a proximal portion 221 of tip capture spindle224, as best shown in FIG. 4A. In the embodiment of FIGS. 2-6, retainerelements 226 are disposed around the circumference of tip capturespindle 224 and each retainer element 226 includes a radially-extendingbase segment 217 and an arm segment 219 that extends distally from basesegment 217 such that arm segment 219 is spaced apart from an outersurface of elongate shaft 212 to define a recess 252 that receives oneor more endmost crowns 242A. When endmost crowns 242A are receivedwithin recesses 252, arm segments 219 of retainer elements 226 distallyand longitudinally extend over and cover endmost crowns 242A to retainthe crowns in a delivery configuration. Arm segments 219 of retainerelements 226 of tip capture spindle 224 can be substantially parallel tothe central or longitudinal axis of elongate shaft 212, i.e., thelongitudinal axis of delivery system 200. In other embodiments, retainerelements 226 can curve toward or away from the longitudinal axis ofdelivery system 200 as desired for a particular purpose. In anembodiment, the number of retainer elements 226 of tip capture spindle224 is equal to half the number of endmost crowns 242A of first endstent 240A and two endmost crowns are received in each recess 252, asbest shown in FIG. 4, in a piggyback or stacking manner to furtherreduce the effective diameter of the delivery system. Struts 240 offirst end stent 240A are of equal length and two crowns 242A are stackeddirectly on top of one another within each recess 252. In anotherembodiment (not shown in FIGS. 2-6), the number of retainer elements 226of tip capture spindle 224 is equal to the number of endmost crowns 242Aof first end stent 240A and one endmost crown is received in eachrecess.

Stent-graft delivery system 200 also includes a retractable outer sheathor graft cover 202 to contain stent-graft prosthesis 230 in aconstrained diameter configuration while the graft delivery system istracked through a body lumen to the deployment site. Graft cover 202 maybe constructed of any suitable flexible polymeric material, includingbut not limited to polyethylene terephalate (PET), nylon, polyethylene,PEBAX, or combinations thereof, either blended or co-extruded. In FIG.2, graft cover 202 is in a non-retracted, delivery configuration. Graftcover 202 defines a lumen 208 extending from a proximal end 204 to adistal end 206, and elongate shaft 212 slidably extends through lumen208 of graft cover 202. Graft cover 202 is movable in an axial directionalong and relative to elongate shaft 212 and extends to a proximalportion of the graft delivery system where it may be controlled via anactuator, such as a handle 210 to selectively expand the graft disposedaround distal end 216 of elongate shaft 212. Handle 210 may be apush-pull actuator that is attached or connected to proximal end 204 ofgraft cover 202. Alternatively, the actuator may be a rotatable knob(not shown) that is attached or connected to proximal end 204 of graftcover 202 such that when the knob is rotated, graft cover 202 isretracted in a proximal direction to expand the graft. Thus, when theactuator is operated, i.e., manually turned or pulled, graft cover 202is proximally retracted over elongate shaft 212 in a proximal direction.

When initial or partial deployment of prosthesis 230 is desired, graftcover 202 is retracted to allow body 238 of prosthesis 230 toself-expand. As shown in FIGS. 3-4, when stent-graft prosthesis 230 isin a partially deployed configuration, endmost crowns 242A of first endstent 240A remain hooked around tip capture spindle 224. Notably,stent-graft prosthesis 230 is still coupled to delivery system 200 ifrepositioning of the stent-graft 230 is required. In the embodimentdepicted in FIG. 3, graft cover 202 is retracted such that a distal endthereof no longer covers or constrains distal or second end 236 ofprosthesis 230, thereby allowing distal or second end 236 of prosthesis230 to self-expand and deploy. In another embodiment hereof (not shown),graft cover 202 is retracted such that a distal end thereof remains overand radially constrains a distal or second end 236 of prosthesis 230 inorder to eliminate or minimize any inclination of prosthesis 230 torotate/spin when elongate shaft 212 is rotated as further describedherein.

After any repositioning is performed and stent-graft prosthesis 230 ispositioned as desired, stent-graft prosthesis 230 may be fully deployedand released from delivery system 200 by rotating or turning elongateshaft 212 to retract tip capture spindle 224. Tip capture retainerelements 226 are retracted until arm segments 219 no longer coverendmost crowns 242A of first end stent 240A, thereby permitting firstend stent 240A to fully expand or deploy as shown in FIG. 5-6. Moreparticularly, spindle 224 is disposed around and rotatable relative toelongate shaft 212, and is coupled to distal tip assembly 228 via athreaded connection. Spindle 224 is also slideable relative to shaft212. In particular, as shown in FIGS. 4, 4A, 6, and 6A, a proximalportion 227 of distal tip assembly 228 includes a recess or bore 251.The bore 251 includes female or internal threads 253. An insert 255 isdisposed in bore 251 and includes external or male threads 257 tointerlock with threads 253. Insert 255 in this embodiment is lockedwithin bore 251 and is considered part of distal tip assembly 228. Aswould be understood by those of ordinary skill in the art, insert 255may be connected to the remainder of distal tip assembly 228 by othermeans, such as adhesives or other mechanical connectors, or may beunitary with the remainder of distal tip assembly 228. Insert 255 alsoincludes a bore 258 there within including internal or female threads229. A distal portion 223 of spindle 224 includes male or externalthreads 225 to mate with threads 229 to convert rotational movement intotranslational or linear movement. Threads 225, 229 are continuoushelical ridges that wrap around an outer surface of spindle 224 and aninner surface of insert 255, respectively, to form a matched or matingpairs of threads. As will be understood by those of ordinary skill inthe art, threads 225, 229 are used to convert rotational totranslational or linear movement. Distal tip assembly 228 also includesa spacer 259 disposed within a recess or pocket at a proximal end ofinsert 255. Spacer 259 is formed from an elastomer material such asrubber, and functions to push and secure endmost crowns 242A ofstent-graft 230 within recesses 252 defined by retainer elements 226when crowns 242A are captured by distal tip spindle 224 in the deliveryconfiguration, as shown in FIG. 4A. Endmost crowns 242A of stent-graft230 are essentially wedged or sandwiched between spacer 259 andradially-extending base segments 217 of retainer elements 226 to preventpremature release of end stent 240A that may otherwise occur if endmostcrowns 242A are not pushed against radially-extending base segments 217of retainer elements 226. As would be recognized by those skilled in theart, spacer 259 may be integral with insert 255, which may be integralwith the remainder of distal tip assembly 228.

In order to move distal tip spindle 224 to release endmost crowns 242Aof stent-graft 230, shaft 212 is rotated. Shaft 212 is coupled to distaltip assembly 228 (including insert 255) such that rotation of shaft 212causes rotation of distal tip assembly 228 (i.e., they are not rotatablerelative to each other). When elongate shaft 212 is rotated, distal tipassembly 228 with insert 255 fixedly attached thereto is also rotated.Distal spindle 224 is prevented from rotation due to endmost crowns 242Aof first end stent 240, which extend between adjacent retainer elements226 of spindle 224. Because spindle 224 is prevented from rotating,rotation of elongate shaft 212 results relative rotation of spindle 224and insert 255 along threads 225, 229, thereby causing the rotationalmovement to be converted to translational or linear movement betweenspindle 224 and tip assembly 228. Because the longitudinal location ofshaft 212 and distal tip assembly is fixed at proximal end 214 of innershaft 212 via a hub or locking component (not shown), spindle 224 islongitudinally driven back or forth along the main or longitudinal axisL_(A) of delivery system 200. If elongate shaft 212 is rotated in afirst direction, i.e. clockwise or counter-clockwise depending upon thedirection of the threaded connection 225, 229 between spindle 224 anddistal tip assembly 228, spindle 224 may be proximally retracted todisengage endmost crowns 242A of first end stent 240A from retainerelements 226 of spindle 226 for final deployment of stent-graftprosthesis 230. Elongate shaft 212 may be rotated via an actuatorcoupled to proximal end 214 thereof, such as a rotatable knob or handle220.

After first end stent 240A is permitted to deploy and crowns 242A offirst end stent 240A no longer extend between adjacent retainer elements226 of spindle 224, continued rotation of elongate shaft 212 does notresult in longitudinal movement of spindle 224 because spindle 224 is nolonger prevented from rotation. Rather, continued rotation of elongateshaft 212 after first end stent 240A is deployed results inspinning/rotation of spindle 224.

A delivery system requiring with a tip capture mechanism as generallydescribed above may also be utilized to deliver and deploy a stent-graftprosthesis having a proximal closed web configuration. In a closed webconfiguration, the endmost crowns do not extend past or beyond the graftmaterial but rather are covered by graft material. Stent-grafts having aclosed web proximal configuration do not have a bare proximal end stentfree to interact with a tip capture spindle of a delivery system. Insome cases a closed web configuration may be required or chosen due toapplication, i.e., a thoraric aortic aneurysm rather than an abdominalaortic aneurysm, and/or user preferences. For example, FIGS. 7-10illustrate another embodiment hereof delivery system 700 having a tipcapture mechanism to allow for partial deployment and repositioning of aself-expanding stent-graft prosthesis 730 which has a proximal closedweb configuration. FIGS. 7, 7A, 8, and 9 illustrate a distal portion ofdelivery system 700 with stent-graft prosthesis 230 in either a deliveryconfiguration or a partially deployed configuration, and FIG. 10illustrates a distal portion of delivery system 700 with delivery system700 in a deployed configuration. In FIG. 10, stent-graft prosthesis 730is still shown with first end stent 740A undeployed for convenience ofseeing the relationship between the stent-graft 730 and the deliverysystem 700, but it would be understood by those having ordinary skill inthe art that once sutures 750 are released from spindle 724, first endstent 740A will self-expand to fully deploy stent-graft prosthesis 730,as described in more detail below. FIG. 7A is a cross-sectional view ofFIG. 7, while FIG. 8 is an end view taken along line A-A of FIG. 7 andFIG. 9 is an enlarged sectional view of a portion of FIG. 7. Similar todelivery system 200, delivery system 700 has a reduced delivery orcrossing profile compared to prior delivery systems and requires lessforce to move the tip capture mechanism for final deployment ofstent-graft 730.

Delivery system 700 includes an elongate shaft 712 having a proximal end(not shown in FIGS. 7-10) and a distal end 716, and a tapered distal tipassembly 728 is coupled to distal end 716 of elongate shaft 712 suchthat distal tip assembly 728 does not rotate relative to shaft 712.Although not shown in FIGS. 7-10, stent-graft delivery system 700 alsoincludes a retractable outer sheath or graft cover (not shown) tocontain stent-graft prosthesis 730 in a constrained diameterconfiguration while the graft delivery system is tracked through a bodylumen to the deployment site. Stent-graft prosthesis 730 is disposedaround elongate shaft 712, proximate to distal end 716. Only a proximalportion of stent-graft prosthesis 730 is shown in FIGS. 7-10.Stent-graft prosthesis 730 is similar to stent-graft prosthesis 230,except that at least a first end 734 of stent-graft prosthesis 730 has aclosed web configuration in which proximal endmost crowns 742A of afirst end stent 740A are covered or lined by a tubular graft 732 and donot extend past or beyond first end 734 of graft 732.

Endmost crowns 742A of end stent 740A may be stitched or otherwisesecured to graft 732 and thus are not free to interact with a tipcapture spindle 724, which is also mounted on elongate shaft 712.Rather, in this embodiment, a plurality of suture loops 750 couple graft732 to retainer elements 726 of tip capture spindle 724. In anembodiment, the number of suture loops 750 and the number of retainerelements 726 are equal to the number of endmost crowns 742A of first endstent 740A and a suture loop 750 couples graft 732 to a respectiveretainer element 726 adjacent to each endmost crown 742A. However, moreor less suture loops and retainer elements may be used. Each suture loop750 passes through the graft material of graft 732, and engages or hooksaround a retainer element 726 of tip capture spindle 724. In anembodiment, as shown in FIG. 7A, each retainer element 726 of tipcapture spindle 724 includes a recess or groove 752 formed on an innersurface thereof for receiving a suture loop 750. Each suture loop 750may be captured between recess 752 of retainer 726 and elongate shaft712. To ensure retention to the suture loop, elongate shaft 712 mayinclude an enlarged portion 754 having an outer diameter greater thanthe outer diameter of the remainder of the shaft 712 and each sutureloop 750 may be received within a recess 752 of retainer 726, adjacentto enlarged portion 754 of elongate shaft 712. Enlarged portion 754 maybe formed by overmoulding material onto elongate shaft 712.

To fully deploy and release stent-graft prosthesis 730 from deliverysystem 700, elongate shaft 712 is rotated to distally advance tipcapture spindle 724, thereby disengaging or removing retainer elements726 of tip capture spindle 724 from suture loops 750 as shown in FIG. 10such that first end stent 740A of stent-graft prosthesis 730 ispermitted to fully expand or deploy. Similar to delivery system 200,spindle 724 is disposed around elongate shaft 712 such that spindle 724may rotate and slide relative to shaft 712. Further, spindle 724 iscoupled to distal tip assembly 728 via a threaded connection. A distalportion 723 of spindle 724 includes male or external threads 725, and aproximal portion 727 of distal tip assembly 728 includes a 251 withfemale or internal threads 729 on an inner surface defined by bore 751.In the embodiment shown in FIGS. 7-10, proximal portion 727 of distaltip assembly 728 is coupled to the remainder of the distal tip assemblyby a lap connection 731. Thus, in the embodiment of FIGS. 7-10, there isno insert 255 as described above with respect to FIGS. 2-6. Those ofordinary skill in the art would recognize that this feature of eitherembodiment can be used interchangeably, and that proximal portion 227,727 of either embodiment may be integral with the remainder of distaldip assembly 228, 728. Threads 725, 729 are continuous helical ridgesthat wrap around an outer surface of spindle 724 and an inner surface ofdistal tip assembly 728, respectively, to form a matched or mating pairsof threads.

In order to move distal tip spindle 724 to release suture loops 750 andthus deploy end 734 of stent-graft 730, shaft 712 is rotated. Shaft 712is coupled to distal tip assembly 728 such that rotation of shaft 712causes rotation of distal tip assembly 728 (i.e., they are not rotatablerelative to each other). Spindle 724 is prevented from rotation due tosuture loops 750. Because spindle 724 is prevented from rotating,rotation of elongate shaft 712 results relative rotation of spindle 724and distal tip assembly 728 along threads 725, 729, thereby causing therotational movement to be converted to translational or linear movementbetween spindle 724 and tip assembly 728. Because the longitudinallocation of shaft 712 and distal tip assembly 728 is fixed at theproximal end (not shown in FIGS. 7-10) of inner shaft 212 via a hub orlocking component (not shown), spindle 724 is longitudinally driven backor forth along the main or longitudinal axis L_(A) of delivery system700. If elongate shaft 712 is rotated in a first direction, i.e.clockwise or counter-clockwise depending upon the direction of thethreaded connection between spindle 724 and distal tip assembly 728,spindle 724 may be distally advanced into distal tip assembly 728 todisengage retainer elements 726 of spindle 724 from suture loops 750 forfinal deployment of stent-graft prosthesis 730.

After first end stent 740A is permitted to deploy and suture loops 750no longer couple first end stent 740A to retainer elements 726 ofspindle 724, continued rotation of elongate shaft 712 does not result inlongitudinal movement of spindle 724 because spindle 724 is no longerprevented from rotation. Rather, continued rotation of elongate shaft712 after first end stent 740A is deployed results in spinning/rotationof spindle 724.

A delivery system with a tip capture mechanism as described above mayalso be utilized to deliver and deploy a stent-graft prosthesis havingone or more barbs on its proximal end. Barbs are spikes or projectionsthat radially extend from a stent when deployed in order to anchor orsecure a stent-graft in place within the vasculature. In some cases abarbed stent-graft may be required or chosen due to application, i.e.,an abdominal aortic aneurysm rather than a thoracic aortic aneurysm,and/or user preferences. For example, FIGS. 11, 11A, 11B, and 12illustrate another embodiment hereof in which a delivery system 1100having an elongated shaft 1112 has a tip capture mechanism to allow forpartial deployment and repositioning of a self-expanding stent-graftprosthesis 1130 which includes at least one barb 1143 on its proximalend, although it will be understood by those of ordinary skill in theart that delivery system 1100 may be utilized to deploy stent-graftprostheses without barbs. In this embodiment, as opposed to a tipcapture spindle being in threaded relationship with the distal tipassembly such that the spindle is longitudinally moved by rotation ofelongate shaft 1112, a relatively short sleeve 1160 that radiallyconstrains the end stent of the stent-graft prosthesis is in a threadedrelationship with the distal tip assembly. Elongate shaft 1112 isrotated to distally advance sleeve 1160, thereby exposing or uncoveringthe end stent to permit self-expansion thereof

More particularly, FIGS. 11, 11A, and 11B illustrate a distal portion ofdelivery system 1100 with stent-graft prosthesis 1130 in either adelivery configuration or a partially deployed configuration, and FIG.12 illustrates a distal portion of delivery system 1100 in a deployedconfiguration. FIG. 11A is a cross-sectional view of FIG. 11, while FIG.11B is an enlarged sectional view of a portion of FIG. 11A. In FIG. 12,stent-graft prosthesis 1130 is still shown with first end stent 1140Aundeployed for convenience of seeing the relationship between first endstent 1140A the and the delivery system 1100, but it would be understoodby those having ordinary skill in the art that once sleeve 1160 is moveddistally to uncover recesses 1162 and crowns 1142A, first end stent1140A first end stent 1140A will self-expand to fully deploy stent graftprosthesis 1130, as described in more detail below. Similar to theembodiments described above, delivery system 1100 has a reduced deliveryor crossing profile compared to prior delivery systems and less force tomove the tip capture mechanism for final deployment of stent-graft 1130.

Elongate shaft 1112 of delivery system 1100 has a proximal end (notshown in FIGS. 11-12) and a distal end 1116. Although not shown in FIGS.11-12, stent-graft delivery system 1100 also includes a retractableouter sheath or graft cover (not shown) to contain stent-graftprosthesis 1130 in a constrained diameter configuration while the graftdelivery system is tracked through a body lumen to the deployment site.Stent-graft prosthesis 1130 is disposed around elongate shaft 1112,proximate to distal end 1116. Stent-graft prosthesis 1130 is similar tostent-graft prosthesis 230 which has an open-web or free-flow proximalend configuration, except that one or more of endmost crowns 1142A of afirst end stent 1140A includes a barb 1143, although delivery system1100 may be utilized to delivery stent-graft prostheses not having abarb thereon. Endmost crowns 1142A extend past or beyond the graftmaterial of stent-graft prosthesis 1130 such that the endmost crowns areexposed or bare, and thus free to interact with a tip capture spindle1124 and couple stent-graft prosthesis 1130 to delivery system 1100. Forillustrative purposes, only a proximal, endmost crown 1142A having abarb 1143 of stent-graft prosthesis 1130 is shown in FIGS. 11-12.

Tip capture spindle 1124 is also disposed over elongate shaft 1112 suchthat tip capture spindle 1124 is rotatable relative to shaft 1112. Inthe delivery configuration or partially deployed configuration shown inFIGS. 11, 11A, and 11B endmost crowns 1142A engage or hook aroundretainer elements 1126 of tip capture spindle 1124. The number ofretainer elements 1126 of tip capture spindle 1124 is equal to thenumber of endmost crowns 1142A of the first end stent 1140A and a singleendmost crown engages or hooks around each single retainer element 1126in a one crown to one retainer ratio. Endmost crowns 1142A are housed ina recess 1162 formed on the outer surface of a retainer 1126 of spindle1124. Barb 1143 is radially constrained by an additional component, arelatively short sleeve 1160 which extends from first end stent 1140A todistal tip assembly 1128.

In this embodiment, distal tip assembly 1128 includes a recess or bore1151 and a proximally-extending tubular portion 1170 is disposed withinbore 1151 and extends over the outer surface of elongate shaft 1112. Thebore 1151 includes female or internal threads 1153. Proximally-extendingtubular portion 1170 includes external or male threads 1157 to interlockwith threads 1153. Proximally-extending tubular portion 1170 in thisembodiment is locked within bore 1151 and is considered part of distaltip assembly 1128. As would be understood by those of ordinary skill inthe art, proximally-extending tubular portion 1170 may be connected tothe remainder of distal tip assembly 1128 by other means, such asadhesives or other mechanical connectors, or may be unitary with theremainder of distal tip assembly 1128. Proximally-extending tubularportion 1170 is also coupled to distal end 1116 of elongate shaft 1112and extends proximally therefrom. Proximally-extending tubular portion1170 is coupled to distal end 1116 of elongate shaft 1112 such thatshaft 1112 and proximally-extending tubular portion 1170 are notrotatable relative to each other.

In this embodiment, sleeve 1160 is in a threaded relationship withproximally-extending tubular portion 1170 of distal tip assembly 1128.More particularly, a proximal portion 1123 of proximally-extendingtubular portion 1170 includes male or external threads 1125 formed onthe outer surface thereof. At least a distal portion 1168 of sleeve 1160includes female or internal threads 1129 on an inside surface thereof.Threads 1125, 1129 are continuous helical ridges that wrap around anouter surface of proximally-extending tubular portion 1170 and an innersurface of sleeve 1160, respectively, to form a matched or mating pairsof threads. When elongate shaft 1124 having distal tip assembly 1128non-rotatably coupled thereto is rotated, spindle 1124 is prevented fromrotation due to endmost crowns 1142A of first end stent 1140, whichextend between adjacent retainer elements 1126 of spindle 1124. Inaddition, spindle 1124 includes a projection or extension pin 1166,which extends from spindle 1124 in a radial direction through a slot1164 formed in sleeve 1160. With pin 1166 extending through slot 1164 ofsleeve 1160, sleeve 1160 is also prevented from rotating when elongateshaft 1162 is rotated. Because sleeve 1160 is prevented from rotatingand the longitudinal location of shaft 1112 and distal tip assembly 1128is fixed at the proximal end (not shown in FIGS. 11-12) of inner shaft1112 via a hub or locking component (not shown), rotation of elongateshaft 1112 results in sleeve 1160 being longitudinally driven back orforth along the main or longitudinal axis L_(A) of delivery system 1100.If elongate shaft 1112 is rotated in a first direction, i.e. clockwiseor counter-clockwise depending upon the direction of the threadedconnection between sleeve 1160 and elongate shaft 1112, sleeve 1160 isdistally advanced to uncover first end stent 1140A for final deploymentof stent-graft prosthesis 1130. As sleeve 1160 moves, pin 1166longitudinally slides within slot 1164 of sleeve 1160. Accordingly, slot1164 is of sufficient length to allow sleeve 1160 to move distally touncover crowns 1142A disposed in recesses 1162 on retainers 1126 ofspindle 1124. Thus, in this embodiment, elongate shaft 1112 and distalassembly 1128 coupled thereto are rotated to distally advance sleeve1160, thereby exposing or uncovering barbs 1143 and endmost crowns 1142Aof first end stent 1140A which were housed within recess 1162 onretainer 1126 as shown in FIG. 12 such that first end stent 1140A ofstent-graft prosthesis 1130 is permitted to fully expand or deploy.

In an embodiment, sleeve 1160 may have a stepped outer diameter in whicha distal portion 1168 of the sleeve has a smaller outer diameter than aproximal portion 1169 of the sleeve. In the delivery or partiallydeployed configurations, proximal portion 1169 covers and restrainsfirst end stent 1140A of stent-graft prosthesis 1130. When elongateshaft 1112 is rotated to distally advance sleeve 1160, distal portion1168 of sleeve 1160 slides into a proximal portion of distal tipassembly 1128 and proximal portion 1169 of sleeve 1160 moves in a distaldirection to uncover first end stent 1140A. Rotation of elongate shaft1112 continues to distally advance sleeve 1160 until pin 1166 abutsagainst the proximal end or edge of slot 1164, at which point proximalportion 1169 of sleeve 1160 no longer covers or constrains endmostcrowns 1142A and end stent 1140A is permitted to deploy.

After first end stent 1140A is permitted to deploy and endmost crowns1142A of first end stent 1140A no longer extend between adjacentretainer elements 1126 of spindle 1124, continued rotation of elongateshaft 1112 does not result in longitudinal movement of spindle 1124because spindle 1124 is no longer prevented from rotation. Rather,continued rotation of elongate shaft 1112 after first end stent 1140A isdeployed results in spinning/rotation of spindle 1124.

Although the embodiment of FIGS. 11-12 are described withproximally-extending tubular portion 1170 being considered part ofdistal tip assembly 1128, it will be apparent to one of ordinary skillin the art that proximally-extending tubular portion 1170 having threads1125 thereof may be mounted over a distal portion of elongate shaft1112. Since elongate shaft 1112 and distal tip assembly 1128 are coupledtogether to rotate simultaneously, the operation of the embodiment ofFIGS. 11-12 is unaltered if proximally-extending tubular portion 1170 ismounted over and attached to elongate shaft 1112 suchproximally-extending tubular portion 1170 rotates with elongate shaft1112.

FIGS. 13, 13A, 13B, 14A, and 14B illustrate another embodiment hereof inwhich a delivery system 1300 has a tip capture mechanism to allow forpartial deployment and repositioning of a self-expanding stent-graftprosthesis 1330 which includes at least one barb 1343 on its proximalend, although it will be understood by those of ordinary skill in theart that delivery system 1300 may be utilized to deploy stent-graftprostheses not having any barbs. FIGS. 13, 13A, and 13B illustrate adistal portion of delivery system 1300 with stent-graft prosthesis 1330in either a delivery configuration or a partially deployedconfiguration, and FIGS. 14A and 14B illustrate a distal portion ofdelivery system 1300 in a deployed configuration. In FIGS. 14A and 14B,stent-graft prosthesis 1330 is still shown with first end stent 1340Aundeployed for convenience of seeing the relationship between first endstent 1340A the and the delivery system 1300, but it would be understoodby those having ordinary skill in the art that once sleeve 1160 does notcover recesses 1362 and crowns 1342A, first end stent 1340A willself-expand to fully deploy stent graft prosthesis 1330, as described inmore detail below. FIG. 13A is a cross-sectional view of FIG. 13, whileFIG. 13B is an enlarged sectional view of a portion of FIG. 13A and FIG.14B is an enlarged sectional view of a portion of FIG. 14A. Similar tothe embodiments described above, delivery system 1300 has a reduceddelivery or crossing profile compared to prior delivery systems andrequires less force to move the tip capture mechanism for finaldeployment of stent-graft 1330. In this embodiment, a relatively shortsleeve 1360 distally advances to uncover and fully deploy stent-graftprosthesis 1330 as described above with respect to sleeve 1160. However,unlike the embodiment of FIGS. 11-12, a tip capture spindle 1324 ofdelivery system 1300 also concurrently moves in a proximal longitudinaldirection during final deployment of stent-graft prosthesis 1330. Byhaving two components that concurrently move in opposing directions,stent-graft prosthesis 1330 is fully deployed by half the rotations ofembodiments having only one moving component as will be explained inmore detail herein.

More particularly, delivery system 1300 includes an elongate shaft 1312having a proximal end (not shown in FIGS. 13-14) and a distal end 1316,and a tapered distal tip assembly 1328 is coupled to distal end 1316 ofelongate shaft 1312 such that distal end assembly 1328 is not rotatableor slideable relative to shaft 1312. Although not shown in FIGS. 13-14,stent-graft delivery system 1300 also includes a retractable outersheath or graft cover (not shown) to contain stent-graft prosthesis 1330in a constrained diameter configuration while the graft delivery systemis tracked through a body lumen to the deployment site. Stent-graftprosthesis 1330 is disposed around elongate shaft 1312, proximate todistal end 1316. Stent-graft prosthesis 1330 is similar to stent-graftprosthesis 1130 which has an open-web or free-flow proximal endconfiguration and one or more endmost crowns 1342A of a first end stent1340A include a barb 1343, although delivery system 1300 may be utilizedto delivery stent-graft prostheses not having a barb thereon. Endmostcrowns 1342A extend past or beyond the graft material of stent-graftprosthesis 1330 such that the endmost crowns are exposed or bare, andthus free to interact with tip capture spindle 1324 and couplestent-graft prosthesis 1330 to delivery system 1300. For illustrativepurposes, only a proximal, endmost crown 1342A having a barb 1343 ofstent-graft prosthesis 1330 is shown in FIGS. 13-14. Delivery system1300 may include a fitting 1378 adjacent to first end stent 1340A.Fitting 1378 is formed from an elastomer material such as rubber, andessentially functions as a shock absorber that minimizes the spacebetween end stent 1340A and elongate shaft 1312. If stent-graftprosthesis 1330 is repositioned after initial deployment, fitting 1378absorbs and dissipates energy resulting from the movement of elongateshaft 1312 during repositioning to prevent unintentional movement offirst end stent 1340A.

Tip capture spindle 1324 is disposed around elongate shaft 1312 suchthat spindle 1324 is rotatable and slideable relative to shaft 1312. Inthe delivery configuration or partially deployed configuration shown inFIGS. 13, 13A, and 13B endmost crowns 1342A engage or hook aroundretainer elements 1326 of tip capture spindle 1324. The number ofretainer elements 1326 of tip capture spindle 1324 is equal to thenumber of endmost crowns 1342A of the first end stent and a singleendmost crown engages or hooks around each retainer element 1326 in aone crown to one retainer ratio. Endmost crowns 1342A are housed in arecess 1362 formed on the outer surface of a retainer 1326 of spindle1324. Barb 1343 is radially constrained by relatively short sleeve 1360which extends from first end stent 1340A to distal tip assembly 1328.

In this embodiment, distal tip assembly 1328 includes a recess or bore1351 and a proximally-extending tubular portion 1370 is disposed withinbore 1351. The bore 1351 includes female or internal threads 1353.Proximally-extending tubular portion 1370 includes external or malethreads 1357 to interlock with threads 1353. Proximally-extendingtubular portion 1370 in this embodiment is locked within bore 1351 andis considered part of distal tip assembly 1328. As would be understoodby those of ordinary skill in the art, proximally-extending tubularportion 1370 may be connected to the remainder of distal tip assembly1328 by other means, such as adhesives or other mechanical connectors,or may be unitary with the remainder of distal tip assembly 1328.Proximally-extending tubular portion 1370 is also coupled to distal end1316 of elongate shaft 1312 and extends proximally therefrom.Proximally-extending tubular portion 1370 is coupled to distal end 1316of elongate shaft 1312 such that shaft 1312 and proximally-extendingtubular portion 1370 are not rotatable relative to each other. Aspherical ball 1372 is held or housed within a hole or opening 1374formed within proximally-extending portion 1370 of distal tip assembly1328. Sleeve 1360 extends over an outer surface of proximally-extendingportion 1370, and includes a continuous helical or spiral groove 1329 onan inside surface thereof Groove 1329 is semi-circular or concave andsized to receive or house half of ball 1372. At least a distal portion1323 of spindle 1324 extends within a bore or lumen 1358 ofproximally-extending portion 1370 and includes a continuous helical orspiral groove 1325 on an outer surface thereof Groove 1325 is alsosemi-circular or concave and sized to receive or house half of ball1372. Groove 1329 of sleeve 1360 aligns with groove 1325 of spindle 1324to create a continuous helical or spiral passageway that is sphericaland sized to house ball 1372. In the delivery or partially deployedconfiguration of FIGS. 13, 13A, and 13B, ball 1372 extends through hole1374 of proximally-extending portion 1370 with a first or “top” half ofthe ball 1372 housed within groove 1329 of sleeve 1360 and a second or“bottom” half of the ball 1372 housed within groove 1325 of spindle1324. Grooves 1325, 1329 have the same pitch but the pitch is inopposing directions, i.e., grooves 1325 have a left hand thread whilegrooves 1329 have a right hand thread or vice versa.

When elongate shaft 1312 and distal tip assembly 1328 coupled thereto isrotated, sleeve 1360 is distally and spindle 1324 is simultaneouslyproximally retracted to uncover recesses 1362 in retaining elements 1326to fully deploy first end stent 1340A of stent-graft prosthesis 1330.More particularly, when elongate shaft 1312 is rotated, spindle 1324 isprevented from rotation due to endmost crowns 1342A of first end stent1340, which extend between adjacent retainer elements 1326 of spindle1324. In addition, spindle 1324 includes a projection or extension pin1366, which extends from spindle 1324 in a radial direction through aslot 1364 formed in sleeve 1360. With pin 1366 extending through slot1364 of sleeve 1360, sleeve 1360 is also prevented from rotating whenelongate shaft 1362 is rotated. However, when elongate shaft 1312 isrotated, proximal-extending portion 1370 of distal tip assembly 1328rotates and thereby causes ball 1372 to spin or rotate. Ball 1372 spinsbut remains in the same longitudinal position, extending through hole1374 of proximally-extending portion 1370. Since the longitudinallocation of shaft 1312 and distal tip assembly 1328 is fixed at theproximal end (not shown in FIGS. 13-14) of inner shaft 1312 via a hub orlocking component (not shown), rotation/spinning of ball 1372 within thecontinuous helical passageway formed by grooves 1325, 1329 of sleeve1360, spindle 1324, respectively, causes or drives sleeve 1360 andspindle 1324 in opposing directions along the main or longitudinal axisL_(A) of delivery system 1300. Because the pitch of grooves 1325, 1329of spindle 1324 and sleeve 1360, respectively, are in opposinglongitudinal directions, spindle 1324 is driven in a proximal directionand sleeve 1360 is driven in a distal direction, thereby exposing oruncovering barbs 1343 and endmost crowns 1342A of first end stent 1340Awhich were housed within recess 1362 on retainer 1326 as shown in FIGS.14A and 14B such that first end stent 1340A of stent-graft prosthesis1330 is permitted to fully expand or deploy. As sleeve 1360 moves, pin1366 longitudinally slides within slot 1364 of sleeve 1360. Accordingly,slot 1364 is of sufficient length to allow sleeve 1360 to move distallyto uncover crowns 1342A disposed in recesses 1362 on retainers 1326 ofspindle 1324. Pin 1366 ensures that spindle 1324 and sleeve 1360 move atthe same time and at the same rate. Without pin 1366, one of the spindleor the sleeve could move through its range of motion without the otherpart advancing at all. However, pin 1366 balances the forces between thetwo moving parts. By having two components moving at the same time inopposing or opposite directions, i.e., sleeve 1360 and spindle 1324,deployment of stent-graft prosthesis 1330 is achieved via half therotations of embodiments having only one moving component. Two movingcomponents have a finer pitch and provide a mechanical advantagecompared to embodiments having only one moving component.

After first end stent 1340A is permitted to deploy and endmost crowns1342A of first end stent 1340A no longer extend between adjacentretainer elements 1326 of spindle 1324, continued rotation of elongateshaft 1312 does not result in longitudinal movement of spindle 1324 andsleeve 1360 because spindle 1324 and sleeve 1360 are no longer preventedfrom rotation. Rather, continued rotation of elongate shaft 1312 afterfirst end stent 1340A is deployed results in spinning/rotation ofspindle 1324 and sleeve 1360.

In an embodiment, sleeve 1360 may have a stepped outer diameter similarto sleeve 1160 in which a distal portion 1368 of the sleeve has asmaller outer diameter than a proximal portion 1369 of the sleeve. Whenelongate shaft 1312 is rotated to distally advance sleeve 1360, distalportion 1368 of sleeve 1360 retreats or slides into a proximal portionof distal tip assembly 1328 and proximal portion 1369 of sleeve 1360moves in a distal direction to uncover first end stent 1340A. Rotationof elongate shaft 1312 continues to distally advance sleeve 1360 untilpin 1366 abuts against the proximal end or edge of slot 1364, at whichpoint proximal portion 1369 of sleeve 1360 no longer covers orconstrains endmost crowns 1342A and end stent 1340A is permitted todeploy.

In addition, as shown in FIGS. 13-14, delivery system 1300 may include arelatively short hypotube 1376 which extends over an outer surface of adistal portion of elongate shaft 1312 from first end stent 1340A, or aproximal end of spindle 1324, to distal end 1316 of elongate shaft 1312.Hypotube 1376 may be formed from stainless steel or other relativelystiff material, and provides pushability and stability to the distalportion of elongate shaft 1312 which may be formed from Nitinol (NiTi).Elongate shaft 1312 rotates within hyptotube 1376, and distal tipassembly 1328 including proximally-extending portion 1370 rotates aroundhypotube 1376. Hypotube 1376 may be included in any delivery systemembodiment described herein.

FIGS. 15, 16, and 16A illustrate yet another embodiment hereof in whicha delivery system 1500 has a tip capture mechanism to allow for partialdeployment and repositioning of a self-expanding stent-graft prosthesis1530 which includes at least one barb 1543 on its proximal end, althoughit will be understood by those of ordinary skill in the art thatdelivery system 1500 may be utilized to deploy stent-graft prosthesesnot having any barbs. FIG. 15 illustrates a distal portion of deliverysystem 1500 with stent-graft prosthesis 1530 in either a deliveryconfiguration or a partially deployed configuration, and FIG. 16illustrates a distal portion of delivery system 1500 in a deployedconfiguration. In FIG. 14, stent-graft prosthesis 1530 is still shownwith first end stent 1540A undeployed for convenience of seeing therelationship between first end stent 1540A the and the delivery system1500, but it would be understood by those having ordinary skill in theart that once sleeve 1560 does not cover recesses 1562 and crowns 1542A,first end stent 1540A will self-expand to fully deploy stent graftprosthesis 1530, as described in more detail below. FIG. 16A is across-sectional perspective view of FIG. 16, with stent-graft prosthesis1530 and elongate shaft 1512 removed for illustrative purposes. Similarto the embodiments described above, delivery system 1500 has a reduceddelivery or crossing profile compared to prior delivery systems and lessforce is required to move the tip capture mechanism for final deploymentof stent-graft 1530. Similar to the embodiment of FIGS. 13-14, a sleeve1560 distally advances to uncover and fully deploy stent-graftprosthesis 1530 and a tip capture spindle 1524 of delivery system 1500proximally retracts during final deployment of stent-graft prosthesis1530. By having two components that concurrently move in opposingdirections, stent-graft prosthesis 1530 is fully deployed by half therotations of embodiments having only one moving component. However, thisembodiment utilizes a double threaded configuration to simultaneouslymove sleeve 1560 and spindle 1524 rather than a spinning ball.

More particularly, delivery system 1500 includes an elongate shaft 1512having a proximal end (not shown in FIGS. 15-16) and a distal end (notshown in the view of FIGS. 15-16), and a tapered distal tip assembly1528 is coupled to the distal end of elongate shaft 1512. Although notshown in FIGS. 15-16, stent-graft delivery system 1500 also includes aretractable outer sheath or graft cover (not shown) to containstent-graft prosthesis 1530 in a constrained diameter configurationwhile the graft delivery system is tracked through a body lumen to thedeployment site. Stent-graft prosthesis 1530 is disposed around elongateshaft 1512, proximate to the distal end. Stent-graft prosthesis 1530 issimilar to stent-graft prosthesis 1130 which has an open-web orfree-flow proximal end configuration and one or more endmost crowns1542A of a first end stent 1540A includes a barb 1543, although deliverysystem 1500 may be utilized to delivery stent-graft prostheses nothaving a barb thereon. Endmost crowns 1542A extend past or beyond thegraft material of stent-graft prosthesis 1530 such that the endmostcrowns are exposed or bare, and thus free to interact with tip capturespindle 1524 and couple stent-graft prosthesis 1530 to delivery system1500. For illustrative purposes, only a proximal, endmost crown 1542Ahaving a barb 1543 of stent-graft prosthesis 1530 is shown in FIGS.15-16.

Tip capture spindle 1524 is also disposed over elongate shaft 1512 suchthat tip capture spindle 1524 is rotatable and slideable relative toshaft 1512. In the delivery configuration or partially deployedconfiguration shown in FIG. 15, endmost crowns 1542A engage or hookaround retainer elements 1526 of tip capture spindle 1524. The number ofretainer elements 1526 of tip capture spindle 1524 is equal to thenumber of endmost crowns 1542A of the first end stent 1540A and a singleendmost crown engages or hooks around each single retainer element 1526in a one crown to one retainer ratio. Endmost crowns 1542A are housed ina recess 1562 formed on the outer surface of a retainer 1526 of spindle1524. Barb 1543 is radially constrained by relatively short sleeve 1560which extends from first end stent 1540A to distal tip assembly 1528.

In this embodiment, distal tip assembly 1528 includes a recess or bore1551 and a proximally-extending tubular portion 1570 is disposed withinbore 1551. The bore 1551 includes female or internal threads 1553.Proximally-extending tubular portion 1570 includes external or malethreads 1557 to interlock with threads 1553. Proximally-extendingtubular portion 1570 in this embodiment is locked within bore 1551 andis considered part of distal tip assembly 1528. As would be understoodby those of ordinary skill in the art, proximally-extending tubularportion 1570 may be connected to the remainder of distal tip assembly1528 by other means, such as adhesives or other mechanical connectors,or may be unitary with the remainder of distal tip assembly 1528.Proximally-extending tubular portion 1570 is also coupled to the distalend of elongate shaft 1512 and extends proximally therefrom.Proximally-extending tubular portion 1570 is coupled to the distal endof elongate shaft 1512 such that shaft 1512 and proximally-extendingtubular portion 1570 are not rotatable relative to each other. An innersurface of proximally-extending portion 1570 is in a threadedrelationship with spindle 1524, and an outer surface ofproximally-extending portion 1570 is in a threaded relationship withsleeve 1560. As to the first threaded relationship between spindle 1524and proximally-extending portion 1570 of distal tip assembly 1528, atleast a distal portion 1523 of spindle 1524 extends within a bore orlumen 1558 of proximally-extending portion 1570 and includes male orexternal threads 1525 formed on the outer surface of the spindle. Atleast a distal portion 1527 of proximally-extending portion 1570includes female or internal threads 1529 on an inside surface thereof.Threads 1525, 1529 are continuous helical ridges that wrap around anouter surface of spindle 1524 and an inner surface ofproximally-extending portion 1570, respectively, to form a matched ormating pairs of threads. As to the second threaded relationship betweenproximally-extending portion 1570 of distal tip assembly 1528 and sleeve1560, a portion 1580 of proximally-extending portion 1570 includes maleor external threads 1582 formed on the outer surface ofproximally-extending portion 1570. Sleeve 1560 extends over an outersurface of proximally-extending portion 1570 and at least a distalportion 1584 of sleeve 1560 includes female or internal threads 1586 onan inside surface thereof. Threads 1582, 1586 are continuous helicalridges that wrap around an outer surface of proximally-extending portion1570 and an inner surface of sleeve 1560, respectively, to form amatched or mating pairs of threads. Mating pair of threads 1525, 1529have the same pitch as mating pair of threads 1582, 1586, but the pitchis in opposing directions, i.e., threads 1525, 1529 have a left handthread while threads 1582, 1586 have a right hand thread or vice versa.

When elongate shaft 1512 and distal tip assembly 1528 coupled theretoare rotated, sleeve 1560 is distally advanced into distal tip assembly1528 and spindle 1524 is simultaneously proximally retracted to fullydeploy first end stent 1540A of stent-graft prosthesis 1530. Moreparticularly, when elongate shaft 1512 is rotated, spindle 1524 isprevented from rotation due to endmost crowns 1542A of first end stent1540, which extend between adjacent retainer elements 1526 of spindle1524. In addition, spindle 1524 includes a projection or extension pin1566, which extends from spindle 1524 in a radial direction through aslot 1564 formed in sleeve 1560. With pin 1566 extending through slot1564 of sleeve 1560, sleeve 1560 is also prevented from rotating whenelongate shaft 1562 is rotated. Because sleeve 1560 and spindle 1524 areprevented from rotating and the longitudinal location of shaft 1512 anddistal tip assembly 1528 is fixed at the proximal end (not shown inFIGS. 15-16) of inner shaft 1512 via a hub or locking component (notshown), rotation of elongate shaft 1512 results in both sleeve 1560 andspindle 1524 being longitudinally driven back or forth along the main orlongitudinal axis L_(A) of delivery system 1500. Because threads 1525,1529 have a left hand thread while threads 1582, 1586 have a right handthread, spindle 1524 is driven in a proximal direction and sleeve 1560is driven in a distal direction thereby exposing or uncovering barbs1543 and endmost crowns 1542A of first end stent 1540A which were housedwithin recess 1562 on retainer 1526 as shown in FIG. 16 such that firstend stent 1540A of stent-graft prosthesis 1530 is permitted to fullyexpand or deploy. As sleeve 1560 moves, pin 1566 longitudinally slideswithin slot 1564 of sleeve 1560. Accordingly, slot 1564 is of sufficientlength to allow sleeve 1560 to move distally to uncover crowns 1542Adisposed in recesses 1562 on retainers 1526 of spindle 1524. Pin 1566ensures that spindle 1524 and sleeve 1560 move at the same time and atthe same rate, as described above with respect to pin 1366.

In an embodiment, sleeve 1560 may have a stepped outer diameter similarto sleeve 1160 in which a distal portion 1568 of the sleeve has asmaller outer diameter than a proximal portion 1569 of the sleeve. Whenelongate shaft 1512 is rotated to distally advance sleeve 1560, distalportion 1568 of sleeve 1560 retreats or slides into a proximal portionof distal tip assembly 1528 and proximal portion 1569 of sleeve 1560moves in a distal direction to uncover first end stent 1540A. Rotationof elongate shaft 1512 continues to distally advance sleeve 1560 untilpin 1566 abuts against the proximal end or edge of slot 1564, at whichpoint proximal portion 1569 of sleeve 1560 no longer covers orconstrains endmost crowns 1542A and end stent 1540A is permitted todeploy.

After first end stent 1540A is permitted to deploy and endmost crowns1542A of first end stent 1540A no longer extend between adjacentretainer elements 1526 of spindle 1524, continued rotation of elongateshaft 1512 does not result in longitudinal movement of spindle 1524 andsleeve 1560 because spindle 1524 and sleeve 1560 are no longer preventedfrom rotation. Rather, continued rotation of elongate shaft 1512 afterfirst end stent 1540A is deployed results in spinning/rotation ofspindle 1524 and sleeve 1560.

While various embodiments according to the present invention have beendescribed above, it should be understood that they have been presentedby way of illustration and example only, and not limitation. It will beapparent to persons skilled in the relevant art that various changes inform and detail can be made therein without departing from the spiritand scope of the invention. For example, in the above embodiments, thescaffolding or support of the stent-graft prostheses have beenillustrated as a series of independent or separate self-expandingstents/sinusoidal patterned rings. However, as will be understood bythose of ordinary skill in the art, the support structure or scaffoldingof a stent-graft prosthesis may have other configurations such as aseries of sinusoidal patterned rings coupled to each other to form aself-expanding stent. In another embodiment, the support structure orscaffolding of a stent-graft prosthesis may be a unitary tubularcomponent having diamond-shaped opening, which may be formed by variousconventional stent forming methods as would be understood by one ofordinary skill in the art. Thus, the breadth and scope of the presentinvention should not be limited by any of the above-described exemplaryembodiments, but should be defined only in accordance with the appendedclaims and their equivalents. It will also be understood that eachfeature of each embodiment discussed herein, and of each reference citedherein, can be used in combination with the features of any otherembodiment. All patents and publications discussed herein areincorporated by reference herein in their entirety.

What is claimed is:
 1. A stent-graft delivery system comprising: anelongate shaft; a tip capture spindle disposed over the shaft, proximateto a distal end of the shaft, wherein a proximal portion of the tipcapture spindle includes a plurality of retainer elements configured toengage a stent of a stent-graft prosthesis and a distal portion of thetip capture spindle includes threads on an outer surface thereof; and adistal tip assembly coupled to the distal end of the shaft, wherein aportion of the distal tip assembly proximally extends over the outersurface of the distal portion of the tip capture spindle and an innersurface of the distal tip assembly includes threads that mate with thethreads on the tip capture spindle, and wherein rotation of the elongateshaft rotates the distal tip assembly and results in longitudinalmovement of the tip capture spindle.
 2. The stent-graft delivery systemof claim 1, further comprising: a retractable outer sheath defining alumen, wherein the elongate shaft is slidingly received within the lumenof the outer sheath; and a self-expanding stent graft prosthesisdisposed over the shaft, proximate to the tip capture spindle, whereinthe stent graft prosthesis includes a radially-compressible stentcoupled to a tubular graft.
 3. The stent-graft delivery system of claim2, wherein endmost crowns of the stent engage the plurality of retainerelements of the tip capture spindle.
 4. The stent-graft delivery systemof claim 3, wherein the endmost crowns of the stent extend beyond afirst end of the tubular graft and the plurality of retainer elements oftip capture spindle cover and constrain the endmost crowns when thestent-graft prosthesis is in a delivery configuration or apartially-deployed configuration.
 5. The stent-graft delivery system ofclaim 4, wherein rotation of the elongate shaft moves the tip capturespindle in a proximal direction.
 6. The stent-graft delivery system ofclaim 4, wherein the retainer elements are disposed around thecircumference of the tip capture spindle and each retainer elementincludes a radially-extending base segment and an arm segment thatdistally extends from the base segment such that the arm segment isspaced apart from an outer surface of the elongate shaft to definerecesses that receive the endmost crowns.
 7. The stent-graft deliverysystem of claim 3, wherein the endmost crowns of the stent do not extendbeyond a first end of the tubular graft and a plurality of suture loopscouple the graft to the plurality of retainer elements of tip capturespindle when the stent-graft prosthesis is in a delivery configurationor a partially-deployed configuration.
 8. The stent-graft deliverysystem of claim 7, wherein rotation of the elongate shaft moves the tipcapture spindle in a distal direction.
 9. The stent-graft deliverysystem of claim 7, wherein each retainer element includes a recessformed on an inner surface thereof for receiving a suture loop and thesuture loop is disposed within the recess of the retainer element andcaptured between the retainer element and an outer surface of theelongate shaft when the stent-graft prosthesis is in a deliveryconfiguration or a partially-deployed configuration.
 10. The stent-graftdelivery system of claim 3, further comprising: a sleeve having aproximal end extending over the retainer elements of the tip capturespindle and a distal end extending into the distal tip assembly, whereinan inner surface of the sleeve includes threads that mates with threadson an outer surface of the distal tip assembly and wherein rotation ofthe elongate shaft rotates the distal tip assembly and results inlongitudinal movement of the tip capture spindle and the sleeve.
 11. Thestent-graft delivery system of claim 10, wherein rotation of theelongate shaft moves the tip capture spindle in a proximal direction andthe sleeve in a distal direction.
 12. The stent-graft delivery system ofclaim 10, wherein the tip capture spindle includes a radially-extendingpin that extends through a slot formed in the sleeve.
 13. A method ofdeploying a stent-graft prosthesis, wherein the method comprises thesteps of: percutaneously advancing a delivery system having astent-graft prosthesis mounted on an elongate shaft, wherein a tipcapture spindle is disposed over the shaft, a proximal portion of thetip capture spindle including a plurality of retainer elements engagedwith a stent of the stent-graft prosthesis, and a distal tip assembly iscoupled to a distal end of the shaft, a portion of the distal tipassembly proximally extending over an outer surface of a distal portionof the tip capture spindle, wherein an inner surface of the distal tipassembly includes threads that mate with threads formed on the outersurface of the distal portion of the tip capture spindle, andpositioning the stent-graft prosthesis; partially deploying thestent-graft prosthesis by retracting an outer sheath of the deliverysystem to expose the stent-graft prosthesis, wherein the stent-graftprosthesis self-expands and the stent remains engaged with the pluralityof retainer elements of the tip capture spindle; rotating the elongateshaft to fully deploy the stent-graft prosthesis, wherein rotation ofthe elongate shaft rotates the distal tip assembly and results inlongitudinal movement of the tip capture spindle.
 14. The method ofclaim 13, further comprising the step of: repositioning the partiallydeployed stent-graft prosthesis, wherein the repositioning step isperformed prior to the step of rotating the elongate shaft to fullydeploy the stent-graft prosthesis.
 15. The method of claim 13, whereinthe endmost crowns of the stent extend beyond a first end of the tubulargraft and the plurality of retainer elements of the tip capture spindlecover and constrain the endmost crowns when the stent-graft prosthesisis in a delivery configuration or a partially-deployed configuration,and wherein rotating the elongate shaft to fully deploy the stent-graftprosthesis moves the tip capture spindle in a proximal direction untilthe retainer elements of the tip capture spindle do not cover theendmost crowns.
 16. The method of claim 13, wherein the endmost crownsof the stent do not extend beyond a first end of the tubular graft and aplurality of suture loops couple the graft to the plurality of retainerelements of tip capture spindle when the stent-graft prosthesis is in adelivery configuration or a partially-deployed configuration, andwherein a plurality of suture loops couple the tubular graft to theplurality of retainer elements and rotating the elongate shaft to fullydeploy the stent-graft prosthesis moves the tip capture spindle in adistal direction until the suture loops do not coupled the tubular graftto the retainer elements of the tip capture spindle.
 17. The method ofclaim 13, wherein the delivery system further includes a sleeve having aproximal end extending over the retainer elements of the tip capturespindle and a distal end extending into the distal tip assembly, whereinan inner surface of the sleeve includes threads that mates with threadson an outer surface of the distal tip assembly, and rotating theelongate shaft to fully deploy the stent-graft prosthesis moves the tipcapture spindle in a proximal direction and moves the sleeve in a distaldirection.
 18. A stent-graft delivery system comprising: an elongateshaft; a tip capture spindle disposed over the shaft, proximate to adistal end of the shaft, wherein the tip capture spindle includes aplurality of retainer elements configured to engage a stent of astent-graft prosthesis; a distal tip assembly coupled to the distal endof the shaft, wherein a portion of the distal tip assembly proximallyextends over elongate shaft and an outer surface of the distal tipassembly includes threads; a sleeve extending over the retainer elementsof the tip capture spindle to the distal tip assembly, wherein an innersurface of the sleeve includes threads that mates with the threads onouter surface of the distal tip assembly, and wherein rotation of theelongate shaft rotates the distal tip assembly and results inlongitudinal movement of the sleeve.
 19. The stent-graft delivery systemof claim 18, wherein rotation of the elongate shaft moves the sleeve ina distal direction.
 20. The stent-graft delivery system of claim 18,wherein the tip capture spindle includes a radially-extending pin thatextends through a slot formed in the sleeve.